Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures

Mandible Fracture Clinical Trial

Official title:

Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530891
• Other study ID #: CEBD-CU-2018-5-4
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: Mohamed N Kadry, MSc
• Phone: +201200560027
• Email: m.kadry2011[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.

Description:

Two groups of patients with anterior mandibular fractures indicated for open reduction and internal fixation. First group will be subjected to computer guided lag screw fixation. Second group will be subjected to traditional lag screw fixation.

Eligible patients will be randomised in equal proportions between study group (computer guided lag screw fixation) and control group (conventional lag screw fixation).

A- Computer guided lag screw fixation group:

• Pre operative Computed tomography will be done for the patient.

• Computed tomography data will be imported into Computer aided surgical simulation software.

• Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced and patient specific surgical guide is designed and sent to three dimension printer before operation.

• Intra operative: All cases will undergo surgery under general anaesthesia.

• Exposure of the fractured segments will be done using vestibular incision.

• Inter-maxillary fixation will be done

• The fractured segments will be reduced in normal anatomic position guided by occlusion.

• Fracture fragments will be fixed using lag screws utilizing patient specific surgical guide.

• Closure of the surgical incision.

• Post operative at first week Computed tomography will be done for the patient.

• Computed tomography data will be imported into computer aided surgical simulation software.

• Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation.

B- Conventional titanium plates:

• Pre operative Computed tomography will be done for the patient.

• Computed tomography data will be imported into Computer aided surgical simulation software.

• Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced.

• Intra operative: All cases will undergo surgery under general anaesthesia.

• Exposure of the fractured segments will be done using vestibular incision.

• Inter-maxillary fixation will be done.

• The fractured segments will be reduced in normal anatomic position guided by occlusion.

• The fracture fragments will be fixed using lag screws.

• Closure of the surgical incision.

• Post operative at first week Computed tomography will be done for the patient.

• Computed tomography data will be imported into computer aided surgical simulation software.

• Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation.

Follow up for both groups:

Clinical evaluation will be performed at first week postoperative then patients will be recalled every week for one month. Final follow up visit will be at 3 months post operative.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Patients with anterior mandibular fracture indicated for open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or mid face.

• All ages and both sexes were included in this study.

• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

• Patients with good general condition allowing major surgical procedure under general anaesthesia .

• Patients with physical and psychological tolerance.

Exclusion criteria:

• Patients with comminuted fractures as it is not indicated for compression osteosynthesis like lag screws.

• Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.

• Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandible Fracture
• Mandibular Fractures

Intervention

Procedure:
• Computer guided lag screw fixation
Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.
• Conventional lag screw fixation
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine - Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Ellis E 3rd, Ghali GE. Lag screw fixation of anterior mandibular fractures. J Oral Maxillofac Surg. 1991 Jan;49(1):13-21; discussion 21-2. — View Citation

Ellis E 3rd. Is lag screw fixation superior to plate fixation to treat fractures of the mandibular symphysis? J Oral Maxillofac Surg. 2012 Apr;70(4):875-82. doi: 10.1016/j.joms.2011.08.042. Epub 2011 Dec 30. — View Citation

Jones JK, Van Sickels JE. Rigid fixation: a review of concepts and treatment of fractures. Oral Surg Oral Med Oral Pathol. 1988 Jan;65(1):13-8. Review. — View Citation

Kallela I, Ilzuka T, Laine P, Lindqvist C. Lag-screw fixation of mandibular parasymphyseal and angle fractures. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Nov;82(5):510-6. — View Citation

Parashar A, Sharma RK. Unfavourable outcomes in maxillofacial injuries: How to avoid and manage. Indian J Plast Surg. 2013 May;46(2):221-34. doi: 10.4103/0970-0358.118597. Review. — View Citation

Retzepi M, Donos N. The effect of diabetes mellitus on osseous healing. Clin Oral Implants Res. 2010 Jul;21(7):673-81. doi: 10.1111/j.1600-0501.2010.01923.x. Epub 2010 May 3. Review. — View Citation

Tiwana PS, Kushner GM, Alpert B. Lag screw fixation of anterior mandibular fractures: a retrospective analysis of intraoperative and postoperative complications. J Oral Maxillofac Surg. 2007 Jun;65(6):1180-5. — View Citation

Xia JJ, Gateno J, Teichgraeber JF, Christensen AM, Lasky RE, Lemoine JJ, Liebschner MA. Accuracy of the computer-aided surgical simulation (CASS) system in the treatment of patients with complex craniomaxillofacial deformity: A pilot study. J Oral Maxillofac Surg. 2007 Feb;65(2):248-54. — View Citation

Zachariades N, Mezitis M, Papademetriou I. Use of lag screws for the management of mandibular trauma. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Feb;81(2):164-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability of fixed fractured segment	stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)	1st week post operative.
Secondary	neurosensory disturbance	presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no)	one month post operative
Secondary	Accuracy of lag screw placement	Accuracy of lag screw placement will be assessed by measuring device: Computer aided surgical simulation (CASS) software, measuring unit: Millimetre	1st week post operative.
Secondary	supplemental fixation devices	The need for intra operative or post operative supplemental fixation devices, measuring device clinical assessment. measuring unit: binary yes or no	intra operative and one month post operative
Secondary	Need for second surgery	The need for second surgical procedure will be assessed by clinical assessment (measuring device). measuring unit: binary (yes or no).	one month post operative